Tradenames starting with "S"

Patents whose numbers are in italics have been extended under 35 USC 156. All expiration dates include applicable Sec. 156 and pediatric (PED) extensions.

Sarclisa (Injection) (Intravenous) isatuximab-irfc
NDA Applicant: Sanofi-Aventis U.S. LLC      BLA No.: 761113  Prod. No.: 001 Rx (100MG/5ML (20MG/ML)); 002 Rx (500MG/25ML (20MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityMar 2, 2027Orphan Designation: Treatment of multiple myeloma
Approved Labeled Indication: SARCLISA is indicated, in combination with pomalidomide and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.
Exclusivity Protected Indication: Indicated in combination with pomalidomide and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.
Exclusivity Type: Orphan Drug ExclusivityMar 31, 2028Orphan Designation: Treatment of multiple myeloma
Approved Labeled Indication: in combination with carfilzomib and dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy
Exclusivity Protected Indication: treatment of adult patients with relapsed or refractory multiple myeloma who have received 1 prior line of therapy, and for treatment of adult patients with relapsed or refractory multiple myeloma who have received 2 to 3 prior therapies excluding patients covered by the indication approved on March 2, 2020

Semglee (Injection) (Subcutaneous) insulin glargine-yfgn
NDA Applicant: Mylan Pharmaceuticals Inc.      BLA No.: 761201  Prod. No.: 001 Rx (1,000UNITS/10ML (100UNITS/ML)); 002 Rx (300UNITS/3ML (100UNITS/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: 1st Interchangeable ExclusivityNov 15, 2022 

Serostim (For Injection) (Subcutaneous) somatropin
NDA Applicant: EMD Serono, Inc.      BLA No.: 020604  Prod. No.: 001 Rx (6MG); 002 Rx (5MG); 003 Rx (4MG) BLA No.: 020604  Prod. No.: 005 Disc (6MG/0.5ML)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityAug 23, 2003Orphan Designation: Treatment of AIDS-associated catabolism/weight loss.
Approved Labeled Indication: Treatment of AIDS wasting or cachexia.

Simponi Aria (Injection) (Intravenous) golimumab
NDA Applicant: Janssen Biotech, Inc.      BLA No.: 125433  Prod. No.: 001 Rx (50MG/4ML (12.5MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivitySep 29, 2027Orphan Designation: Treatment of polyarticular juvenile idiopathic arthritis in patients 0 through 18 years of age.
Approved Labeled Indication: treatment of active polyarticular juvenile idiopathic arthritis (pJIA) in patients 2 years of age and older
Exclusivity Protected Indication: treatment of active polyarticular juvenile idiopathic arthritis (pJIA) in patients 2 to 18 years of age

Simulect (For Injection) (Intravenous) basiliximab
NDA Applicant: Novartis Pharmaceuticals Corporation      BLA No.: 103764  Prod. No.: 001 Rx (20MG); 002 Rx (10MG)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityMay 12, 2005Orphan Designation: Prophylaxis of solid organ rejection.
Approved Labeled Indication: Prophylaxis of acute organ rejection in patients receiving renal transplantation when used as part of an immunosuppressive regimen that includes cyclosporine and corticosteroids.

Skysona (Injection) (Intravenous) elivaldogene autotemcel
NDA Applicant: Bluebird Bio Inc.      BLA No.: 125755  Prod. No.: 001 Rx (2-30 _ 10^6 CELL/ML)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivitySep 16, 2029Orphan Designation: Treatment of andrenoleukodystrophy
Approved Labeled Indication: To slow the progression of neurologic dysfunction in boys 4-17 years of age with early, active cerebral adrenoleukodystrophy (CALD)
Exclusivity Protected Indication: To slow the progression of neurologic dysfunction in boys 4-17 years of age with early, active cerebral adrenoleukodystrophy (CALD)
Exclusivity Type: Ref. Product ExclusivitySep 16, 2034 

Soliris (Injection) (Intravenous) eculizumab
NDA Applicant: Alexion Pharmaceuticals, Inc.      BLA No.: 125166  Prod. No.: 001 Rx (300MG/30ML (10MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityMar 16, 2014Orphan Designation: Treatment of paroxysmal nocturnal hemoglobinuria
Approved Labeled Indication: Treatment of paroxysmal nocturnal hemoglobinuria to reduce hemolysis
Exclusivity Type: Orphan Drug ExclusivitySep 23, 2018Orphan Designation: Treatment of atypical hemolytic uremic syndrome
Approved Labeled Indication: For the treatment of atypical Hemolytic Uremic Syndrome (aHUS)
Exclusivity Type: Orphan Drug ExclusivityOct 23, 2024Orphan Designation: Treatment of Myasthenia Gravis
Approved Labeled Indication: for the treatment of adult patients with generalized Myasthenia Gravis (gMG) who are anti-acetylcholine receptor (AchR) antibody positive
Exclusivity Protected Indication: for the treatment of adult patients with generalized Myasthenia Gravis (gMG) who are anti-acetylcholine receptor (AchR) antibody positive
Exclusivity Type: Orphan Drug ExclusivityJun 27, 2026Orphan Designation: Treatment of neuromyelitis optica
Approved Labeled Indication: Soliris is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.
Exclusivity Protected Indication: For the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive

Somavert (For Injection) (Subcutaneous) pegvisomant
NDA Applicant: Pharmacia & Upjohn Company LLC      BLA No.: 021106  Prod. No.: 001 Rx (10MG); 002 Rx (15MG); 003 Rx (20MG); 004 Rx (25MG); 005 Rx (30MG)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityMar 25, 2010Orphan Designation: Treatment of acromegaly.
Approved Labeled Indication: Treatment of acromegaly in patients who have had an inadequate response to surgery and/or radiation therapy and/or other medical therapies, or for whom these therapies are not appropriate

Spevigo (Injection) (Intravenous) spesolimab-sbzo
NDA Applicant: Boehringer Ingelheim Pharmaceuticals, Inc.      BLA No.: 761244  Prod. No.: 001 Rx (450MG/7.5ML (60MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivitySep 1, 2029Orphan Designation: Treatment of generalized pustular psoriasis
Approved Labeled Indication: Treatment of generalized pustular psoriasis (GPP) flares in adults
Exclusivity Protected Indication: Treatment of generalized pustular psoriasis (GPP) flares in adults

Stelara (Injection) (Subcutaneous) ustekinumab
NDA Applicant: Janssen Biotech, Inc.      BLA No.: 125261  Prod. No.: 001 Rx (45MG/0.5ML); 003 Rx (45MG/0.5ML); 004 Rx (90MG/ML) BLA No.: 125261  Prod. No.: 002 Disc (90MG/ML)
PatentsExpirationPatented Use
Pat. No. 6902734 [Extended 425 days (1.2 years)]
Anti-IL-12 antibodies and compositions thereof
Claim Types: Compound; Composition
Pat. Sub. Date(s): None		Sep 25, 2023 
Pat. No. 8852889 Cell culture process
Claim Types: Process
Pat. Sub. Date(s): None		Jul 6, 2032 
Pat. No. 9217168 Methods of cell culture
Claim Types: Process
Pat. Sub. Date(s): None		Mar 14, 2033 
Pat. No. 9475858 Cell culture process
Claim Types: Process
Pat. Sub. Date(s): None		Jul 6, 2032 
Pat. No. 9663810 Methods of cell culture
Claim Types: Process
Pat. Sub. Date(s): None		Mar 14, 2033 
Pat. No. 10961307 Methods of treating moderately to severely active ulcerative colitis by administering an anti-IL12/IL23 antibody
Claim Types: Method of use
Pat. Sub. Date(s): None		Sep 24, 2039 

Stelara (Injection) (Intravenous) ustekinumab
NDA Applicant: Janssen Biotech, Inc.      BLA No.: 761044  Prod. No.: 001 Rx (130MG/26ML (5MG/ML))
PatentsExpirationPatented Use
Pat. No. 6902734 [Extended 425 days (1.2 years)]
Anti-IL-12 antibodies and compositions thereof
Claim Types: Compound; Composition
Pat. Sub. Date(s): None		Sep 25, 2023 
Pat. No. 8852889 Cell culture process
Claim Types: Process
Pat. Sub. Date(s): None		Jul 6, 2032 
Pat. No. 9217168 Methods of cell culture
Claim Types: Process
Pat. Sub. Date(s): None		Mar 14, 2033 
Pat. No. 9475858 Cell culture process
Claim Types: Process
Pat. Sub. Date(s): None		Jul 6, 2032 
Pat. No. 9663810 Methods of cell culture
Claim Types: Process
Pat. Sub. Date(s): None		Mar 14, 2033 
Pat. No. 10961307 Methods of treating moderately to severely active ulcerative colitis by administering an anti-IL12/IL23 antibody
Claim Types: Method of use
Pat. Sub. Date(s): None		Sep 24, 2039 

StrataGraft (Cell Sheets) (Topical) Allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen-dsat
NDA Applicant: Stratatech Corporation      BLA No.: 125730  Prod. No.: 001 Rx (100CM SQUARED)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityJun 15, 2028Orphan Designation: Treatment of hospitalized patients with complex skin defects resulting from partial and full thickness skin burns requiring excision and grafting
Approved Labeled Indication: Treatment of adults with thermal burns containing intact dermal elements for which surgical intervention is clinically indicated (deep partial-thickness burns)
Exclusivity Protected Indication: Treatment of adults with thermal burns containing intact dermal elements for which surgical intervention is clinically indicated (deep partial-thickness burns)
Exclusivity Type: Ref. Product ExclusivityJun 15, 2033 

Strensiq (Injection) (Subcutaneous) asfotase alfa
NDA Applicant: Alexion Pharmaceuticals, Inc.      BLA No.: 125513  Prod. No.: 001 Rx (18MG/0.45ML); 002 Rx (28MG/0.7ML); 003 Rx (40MG/ML); 004 Rx (80MG/0.8ML)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityOct 23, 2022Orphan Designation: Treatment of hypophosphatasia
Approved Labeled Indication: For the treatment of patients with perinatal/infantile-and juvenile-onset hypophosphatasia (HPP)
Exclusivity Protected Indication: For the treatment of patients with perinatal/infantile-and juvenile-onset hypophosphatasia (HPP)

Sucraid (Solution For Oral) (Oral) sacrosidase
NDA Applicant: QOL Medical, LLC      BLA No.: 020772  Prod. No.: 001 Rx (1,003,000IU/118ML (8,500IU/ML)); 002 Rx (17,000IU/2ML (8,500IU/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityApr 9, 2005Orphan Designation: Treatment of congenital sucrase-isomaltase deficiency
Approved Labeled Indication: Oral replacement therapy of the genetically determined sucrase deficiency, which is part of congenital sucrease-isomaltase deficiency.

Survanta (Suspension) (Intratracheal) beractant
NDA Applicant: AbbVie Inc.      BLA No.: 020032  Prod. No.: 001 Rx (100MG/4ML (25MG/ML)); 002 Rx (200MG/8ML (25MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityJul 2, 1998Orphan Designation: This Orphan Designation could not be obtained via our automated process due to a trademark mismatch between the Purple Book and the FDA's "Orphan Drug Designations and Approvals" search engine. Please use the FDA's search engine to manually look up the orphan designation.

Sylvant (For Injection) (Intravenous) siltuximab
NDA Applicant: EUSA Pharma (UK) Limited      BLA No.: 125496  Prod. No.: 001 Rx (100MG); 002 Rx (400MG)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityApr 23, 2021Orphan Designation: Treatment of Castleman's disease
Approved Labeled Indication: Treatment of patients with multicentric Castleman's disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative.
Exclusivity Protected Indication: Treatment of patients with multicentric Castleman's disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative.


Last edited: 19 August 2023
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